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NCT03738878

Mechanism(s) Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 1

Terminated Phase 4 Results posted Last updated 3 August 2025
What this trial tests

Phase 4 trial testing Valsartan in Hypertension in 4 participants. Terminated before completion.

Timeline
15 November 2018
Primary endpoint
1 December 2024
1 December 2024

Quick facts

Lead sponsorVanderbilt University Medical Center
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposebasic science
Enrollment4
Start date15 November 2018
Primary completion1 December 2024
Estimated completion1 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 60, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Forearm Blood Flow Primary · After four-week treatment with each crossover drug

Forearm blood flow measured by strain gauge plethysmography before and after intra-arterial peptide infusion

GroupValue95% CI
LCZ6962.462.46 – 2.46
Valsartan2.992.99 – 2.99

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over the full duration of the study - approximately 12 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LCZ966
Serious: 0/1 (0%)
Deaths: 0/1
Valsartan
Serious: 0/1 (0%)
Deaths: 0/1
Other adverse events (1 terms — click to expand)

ReactionSystemLCZ966Valsartan
hypotensionVascular disorders

Data from ClinicalTrials.gov NCT03738878 adverse events section.

Sponsor's own description

The purpose of this study is to test the hypothesis that combined angiotensin receptor blockade (ARB)/neprilysin (NEP) inhibition potentiates the effects of exogenous bradykinin, substance P, and brain natriuretic peptide (BNP) on forearm blood flow or endothelial tissue-type plasminogen activator (t-PA) release compared to ARB alone. A secondary goal is to determine if there is an interactive effect of ARB/NEP inhibition and dipeptidyl peptidase 4 (DPP4) inhibition on responses to these peptides.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Valsartan

Trials testing the same drug.

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03738878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing